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EU: The 16th amendment to the EU plastic food contact regulation adopted

JULY 2023 - ELECTRICAL AND ELECTRONICS, HARDLINES, TOYS AND CHILDREN'S PRODUCTS

The European Commission published Regulation (EU) 2023/14421 on 12 July 2023. This regulation amends Annex I to Food Contact Plastic Regulation (EU) No 10/2011 which will enter into force on 1 August 2023.

Regulation (EU) No 10/2011 has been updated for the 16th time since its first publication. The amendment brings changes to substance authorisations and introduces new substances in Annex I of the Regulation. Significant changes in this revision are summarised below.

In point 1, Table 1:

  • Revokes authorization of substances untreated wood flour and fiber (No. 96) and salicylic acid (No. 121) [See remark 1]
  • Adds five (5) new substances (No.1078, 1080-1083)
  • Replaced nine (9) substances, including new requirements of specified phthalic acids. An overview of the authorisation of phthalic acids in the Regulation is shown as follows: 

Substance 

(FCM No.)

CAS No. The 16th amendment (EU) 2023/1442
(EU) No 10/2011 up to the 15th amendment
SML (mg/kg)
SML(T) (mg/kg)
SML (mg/kg) SML(T) (mg/kg)
DBP (157)
84-74-2
0.12

60 (entry 32)

0.6 (entry 36) 
0.3
60 (entry 32)
BBP (159)
85-68-7
6.0 30
DEHP (283) 117-81-7
0.6 1.5
*DIBP (1085)
 84-69-8
- -  -
DINP (728)
68515-48-0
28553-12-0
- 60 (entry 32)

**1.8 (entry 26)
- 60 (entry 32)

9 (entry 26)
DIDP (729)
84-69-5
- -
* Not authorised
** Do not use with substances No. 157, 159, 283 or 1085.

 

In point 2, Table 2:

Adds new entries 36, 37, 38
Amends three (3) entries in the group restriction of substances by:

adding No. 1081 substance in entry 7;
updating the new SML(T) from 9 mg/kg to 1.8 mg/kg in entry 26;
adding No. 1078 and No. 1085 substances in entry 32 and inserting a description of No. 1085 substance DIBP. [See remark 2]

In point 3, Table 3:

Adds new entry 30 with a note on verification of compliance regarding the thickness of the plastic, polarity of the polymer and degree of esterification of the substance itself.

Remarks
  1. Plastic materials and articles manufactured with salicylic acid (No. 121) or manufactured with untreated wood flour or fibers from a specific wood species (No. 96) may continue to be first placed on the market after 1 February 2025 provided that the specified conditions are fulfilled.
  2. DIBP is not listed as an authorised substance but may co-occur with other phthalates.

Abbreviations

  • SML: Specific migration limit
  • SML(T): Total specific migration limit
  • DBP: Phthalic acid, dibutyl ester
  • BBP: Phthalic acid, benzyl butyl ester
  • DEHP: Phthalic acid, bis(2-ethylhexyl) ester
  • DINP: Phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60% C9
  • DIDP: Diisobutyl phthalate

 

[1] Regulation (EU) 2023/1442


 

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